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Vital Signs

by Oxehealth Limited United Kingdom EUDAMED510(k)GUDID

Ref Vital Signs Product code QMEEMDN Z1203020292

Overview

The Vital Signs device is classified as a Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and Respiratory Rate, per nomenclature code Z1203020292. It functions as a non-invasive monitoring system designed to capture and analyze physiological metrics using optical camera technology, enabling real-time assessment of cardiovascular parameters without direct patient contact.

This device is supplied as a non-sterile, non-reusable, non-implantable Class IIa medical device, intended for single-use applications. It is not MRI-safe, and no reprocessing is permitted. The device is authorized under FDA 510K clearance (K211906) and MDR compliance, with a UDI (506075145VITALSIGNSFF) for traceability. Storage and handling follow standard non-sterile medical device protocols, adhering to regulatory requirements for optical measurement software.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK251200 Date2 Feb 2026IssuedStatusActive
United StatesGUDID listing GUDID Number50607514500009 UDI-DIDate21 Jan 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number506075145VITALSIGNSFF Basic UDI-DIDate4 Aug 2023RegisteredStatusActive
United StatesFDA De Novo 510(k) NumberDEN200019 Date26 Mar 2021IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k), FDA De Novo Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 25 Oct 2026

Generic Name
Near-infrared camera vital sign measurement software
Model / Reference
Vital Signs EUDAMED
2 GUDID
Primary DI / UDI-DI
50607514500009
Basic UDI-DI
506075145VITALSIGNSFF
FDA Product Code
QME
EMDN Code
Z1203020292 Multi-parameter monitors - medical device software
GMDN Term
Near-infrared camera vital sign measurement software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2785
Special Device Type
Software
Market of Registration
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Vital Signs
GUDID
2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000010055
Authorised representative
Oxehealth AB SE-AR-000005038

Other devices from Oxehealth Limited

Questions

  • How is the Vital Signs device intended to be used in clinical settings, and what physiological metrics does it measure?

    The Vital Signs device is a non-invasive, single-use software-based system that uses optical camera technology to measure pulse rate, heart rate, breathing rate, and respiratory rate in real-time. It is designed for monitoring cardiovascular parameters without direct patient contact, making it suitable for remote or non-contact assessments in clinical or home settings.

  • Is the Vital Signs device reusable, and if not, what are the implications for its use and disposal?

    No, the Vital Signs device is explicitly designed for single-use only and is not intended for reuse or reprocessing. This means each device must be discarded after one use, adhering to standard non-sterile medical device disposal protocols to ensure patient safety and compliance with regulatory requirements.

  • What storage and handling guidelines should be followed for the Vital Signs device to maintain its integrity?

    The Vital Signs device follows standard non-sterile medical device protocols for storage and handling. Since it is non-sterile and non-reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following manufacturer instructions to preserve its functionality and ensure accurate measurements.

  • What regulatory pathways does the Vital Signs device follow, and how does this affect its traceability?

    The Vital Signs device is authorized under FDA 510K clearance (K211906) and complies with MDR (Medical Device Regulation) requirements. It includes a UDI (506075145VITALSIGNSFF) for traceability, allowing healthcare providers and regulatory bodies to track its distribution and ensure compliance with global medical device regulations.

  • Can the Vital Signs device be used in environments with MRI machines, and what safety considerations apply?

    The Vital Signs device is explicitly labeled as not MRI-safe, meaning it should not be used in or near MRI environments. This is because optical camera-based devices may interfere with MRI systems or be affected by electromagnetic fields, posing risks to both the device and the patient.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED edb66836-7080-451c-9f55-b3801e70cc0f 61 fields · synced 25 Oct 2026
  • FDA UDI 614c0f06-d4b3-4757-bf0c-97d205bc42ea 33 fields · synced 30 May 2026
  • FDA 510(k) K220899 1 fields · synced 18 May 2026